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Changes in Pleural Cavity Volume and Surgical Exposure

Changes in Pleural Cavity Volume and Surgical Exposure Through Suture Retraction of the Diaphragm During VATS Procedures

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04837950
Enrollment
40
Registered
2021-04-08
Start date
2020-09-29
Completion date
2021-05-31
Last updated
2021-04-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Thoracic Cancer

Brief summary

The investigators want to investigate if a diaphragmatic traction-suture affects the pleural cavity volume, as well as improves visual overview of a surgical field during minimally invasive thoracic surgery.

Detailed description

A visually good surgical field is essential in performing safe and optimal dissection of anatomical structures during Video Assisted Thoracoscopic Surgery (VATS). A number of patients referred to VATS-surgery appear with an elevated diaphragm, reducing visibility and complicating safe surgical techniques, thus entailing conversion from VATS into an open Thoracotomy. Some surgeons handle the decreased visibility due to an elevated diaphragm by increasing the amount of ports during VATS. Others have benefited from attaching a traction suture on the diaphragmatic posterior tendinous part, thus flatting the diaphragmatic dome when the suture is tightly retracted through the camera-port. It turns out that most thoracic surgery clinics are not familiar with this technique. There are also no articles regarding this topic in medical literature. We want to investigate if the diaphragmatic traction-suture affects the pleural cavity volume, as well as improves visual overview of a surgical field during minimally invasive thoracic surgery.

Interventions

PROCEDUREDiaphragmatic traction-suture

Measurement of pleural cavity volume before pulling the diaphragmatic traction-suture Measurement of pleural cavity volume after pulling the diaphragmatic traction-suture

Sponsors

Odense University Hospital
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)

Masking description

Volume of saline in pleural cavity and surgical field overview before and after pulling traction suture

Intervention model description

During video-assisted thoracoscopic surgery a diaphragmatic traction-suture is placed posteriorly at the border between the central tendinous part and the peripheral muscular part. Body temperate saline solution is then poured into the pleural cavity until the cavity is filled up to the soft-tissue retractor in the utility port. The volume of saline in the pleural cavity is then measured and registered before and after distal contraction of the diaphragmatic traction suture through the camera port. Subsequently the surgeon will be asked to evaluate and rate the surgical field visual overview, before and after contraction of the suture. Furthermore, anonymized video recordings focusing on the pleural cavity visual overview before and after distal contraction of the suture, will be presented to specialist thoracic surgeons for a blinded evaluation.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* known or suspected lung cancer * scheduled for VATS-surgery * perioperative finding of elevated diaphragma

Exclusion criteria

* not willing to give informed consent. * perioperative finding of pleural adherences * perioperative finding without an elevated diaphragma

Design outcomes

Primary

MeasureTime frameDescription
Pleural cavity volume before1 minute after applying the traction suturePleural cavity volume (ml) before distal retraction of the diaphragmatic traction suture.
Pleural cavity volume after2 minute after applying the traction suturePleural cavity volume (ml) after distal retraction of the diaphragmatic traction suture.

Secondary

MeasureTime frameDescription
Visual overview1 minute after applying the traction sutureThe surgeon's evaluation of the surgical field visual overview before and after distal retraction of the diaphragmatic traction suture using a numeric rating scale (1-10).

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 14, 2026